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FDA refuses review of mRNA flu vaccine

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 · 2d · on MSN
FDA refuses to review Moderna’s mRNA flu vaccine application
FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

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 · 2d
Moderna says FDA refuses its application for new mRNA flu vaccine
 · 1d
FDA defends its decision not to review Moderna's mRNA flu shot
 · 1d
FDA defends its decision to refuse review of Moderna's flu vaccine
Shares of Moderna (MRNA.O) slumped nearly 9% in premarket trading on Wednesday after the U.S. Food and Drug Administration declined to review the company's application for approval of its experimental...

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 · 13h
Moderna beats quarterly revenue estimates on resilient sales of COVID shot
 · 1d
FDA refuses Moderna's application for new mRNA flu vaccine
Blockonomi
11h

Moderna (MRNA) Stock Slips Despite Beating Q4 Revenue and Earnings Estimates

Moderna (MRNA) stock fell 0.3% Friday despite beating Q4 revenue estimates at $678M and posting narrower loss of $2.11/share after FDA rejected flu vaccine review.
2d

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna
BioPharma Dive
2d

FDA refuses to review Moderna’s mRNA flu vaccine

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.
24/7 Wall St.
1d

Biotech Turnaround: How Moderna Went From Revenue Collapse to YTD Rally Leader

Moderna Inc (NASDAQ:MRNA) has delivered a 37% gain year-to-date, dramatically outpacing the biotech sector’s 0.4% YTD return. In fact, Moderna has the 12th-best gains in the entire S&P 500 so far in 2026!
2d

Moderna Announces Strategic Collaboration with Recordati to Globally Commercialize Investigational Propionic Acidemia Therapeutic (mRNA-3927)

Moderna will continue to lead clinical development and manufacturing for mRNA-3927Moderna to receive up to $160 million
2d

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for a mRNA-based flu vaccine over concerns about the choice of vaccine tested against the experimental vaccine in Phase 3 clinical trials. Moderna described the FDA as “inconsistent” in its communications.
Kalkine Media
2d

Moderna (NASDAQ:MRNA) Aligned With Nasdaq Index Biotech Presence

Moderna advances messenger RNA platform technologies Therapeutics pipeline spans vaccines and disease targets nasdaq index inclusion reflects biotech scale Moderna, Inc. (NASDAQ:MRNA) operates within the biotechnology sector and remains a recognized component of the broader nasdaq index,
3d

Moderna Patent Ruling And New Development Chief Reframe mRNA Growth Story

Moderna (NasdaqGS:MRNA) is involved in an ongoing patent infringement case related to its COVID-19 vaccine, with a recent court ruling addressing claims from Arbutus Biopharma and Genevant. The company has appointed Dr.
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